Hengrui's CDK4/6 inhibitor first to reach Phase III



China-based Jiangsu Hengrui Medicine Co., Ltd (600276.SH)'s SHR6390, a cyclin-dependent kinase (CDK) 4/6 selective inhibitor, has entered into a Phase III clinical trial, according to the Chinadrugtrials.org website. The indication is for HR-positive, HER2-negative locally advanced or metastatic breast cancer.

Belonging to the silk/threonine protein kinase family, the CDK protein kinase family plays an important regulatory role in cell cycle and transcriptional processes for the regulation of intracellular and extracellular signalling, and is a hot target for anti-tumor therapies. Three CDK inhibitors are currently marketed globally: Pfizer's Ibrance (palbociclib), Novartis's Kisqali (ribociclib), and Eli Lilly's Verzenio (abemaciclib), all indicated as breast cancer treatments.

Ibrance is the only CDK4/6 inhibitor commercially available in China, where it was first approved in July 2018. Domestic firms with CDK4/6 inhibitors under development include Chia Tai Tianqing, Betta Pharma, Fosun Pharma, Sihuan Pharma, CStone Pharma, Beta Pharma, and Guangzhou BeBetter Medicine Technology Co., Ltd, in addition to Hengrui. Hengrui's SHR6390 is the first domestic CDK4/6 inhibitor to reach the Phase III clinical trial stage.

Reference:

Related news
China's National Healthcare Security Administration (NHSA) this week released finalized plans for the National Reimbursement Drug List (NRDL) update set to take place this year, one month after the release of draft proposals.
GBI was in attendance at the 2019 China International Pharmaceutical Innovation Forum (IPIF19) held in Beijing today.
China-based Sihuan Pharmaceutical Holdings Group Ltd (460.HKSE) announced strong results, described as "breakthrough", in a Phase I study in China for its self-developed biluoxini (吡罗西尼), a cyclin-dependent kinase inhibitor 4/6(CDK4/6) inhibitor.
  • 1553065450525
  • China
  • Drug
According to GBI analysis, pharma major Eli Lilly this week obtained marketing approval from Brazil's National Health Surveillance Agency (ANVISA) for its oral drug Verzenios (abemaciclib) designed to treat advanced or metastatic HR+/HER2− breast cancer.
According to Carlos Murillo, president of Pfizer Brasil, the company has regained growth and expects to maintain it until 2020.
Recent news
The National Medical Products Administration (NMPA) has issued an interpretation setting our various administrative instructions, covering the filing of imported generic drugs under the new chemical drug registration categories issued in 2016, details of fees payable, and management of category 5.2 imported generic drugs. The document notes that fresh filings of Category 2 innovative chemical drugs, referring to improved versions of known active ingredients, must still pay a registration fee.
A Sino-US team of researchers have reported developing a new improved chimeric antigen receptor (CAR) T cell therapy, according to a study published in Nature Medicine.
  • 1556168634038
  • China
  • R&D
China-based Viva Biotech Holdings (1873.HK) announced an initial public offering (IPO) of 345,000,000 shares with price ranging from HKD 3.42 to HKD 4.41 per share.
Switzerland-based ADC Therapeutics and the China-based Adagene announced a discovery partnership and licensing deal focused on the development of next-generation masked antibody drug conjugates (ADCs).
U.S.-based Boston Children's Hospital (BCH) and Sino-US high-end clinics operator and healthcare service provider MORE Health Inc., announced a strategic partnership that will allow Chinese patients to access BCH's physicians for diagnosis and treatment.
China’s National Medical Products Administration (NMPA) released the medical devices awarded market approval during March 2019.
The Brazilian Society of Diabetes (SBD) this week will discuss the benefits of Technosphere insulin, a fast-acting inhalable diabetes treatment.

Transparent data, powerful analytics and executable insights.